Consulting for clinical and regulatory affairs

The ever-increasing requirements for medicinal products and medical devices must be implemented in the best registration strategy with optimal use of resources during implementation. The proof of efficacy and safety of your product requires an sciene-based strategy that complies with regulatory directives, as well as professional management of clinical studies (clinical trials) and careful documentation for the relevant filing during each phase of implementation.

For preclinical and clinical requirements we develope science-based strategies that comply with regulatory directives. Trial protocols and study designs for safety / tolerability tests and clinical studies we formulate in close coordination and collaboration with appropriate and verified clinical research organisations (CROs), physician, biometricians and you.

Paediatric application in the Paediatric Investigation Plan (PIP) and the current requirements of benefit assessment we also take into consideration.

An important milestone in your project is accomplished through coordination and monitoring of clinical projects in scientific advice meetings with regulatory authorities.

 
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We offer the following services:

  • Consulting of regulatory approval processes for clinical trials
  • Approval strategies: analysis of regulatory barries and options
  • Scientific advice meetings with regulatory authorities
  • Creation of IMPD (Investigational Medicinal Product Dossier), trial protocol, case report form (CRF), final report, etc.
  • Pre-clinical and clinical expert reports
  • Consultation of paediatric drugs:
    • PUMA approvals
    • Creation of Paediatric Investigation Plan (PIP), Waiver, Deferral
  • Labelling

For your clinical study, our project management team assists in the entire process from the development of the strategy, including the Paediatric Investigation Plan (PIP), to the incorporation of the results into the approval application.


Benefits for you:

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  • Your project benefits from experience spanning nearly 20 years
  • Development of customized strategies
  • Our ongoing objective: streamlining the clinical development programme
  • Planning reliability through consultation with the authorities in scientific advice meetings
  • Professional project planning and timely project management from clinical testing to approval